FDA Adverse Event
Injury
Summary report: N
SJM MECHANICAL HEART VALVE (UNKNOWN)
MDR report key: 4233150
·
Received November 6, 2014
Report
- Report Number
- 2648612-2014-00051
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- October 9, 2014
- Report Date
- October 15, 2014
- Manufacturer
- ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
- Product Code
- LWQ
- PMA / PMN Number
- PP810002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
IMPLANT DATE WAS UPDATED. THE RESULTS OF THIS INVESTIGATION CONCLUDED THE LEAFLETS WERE WITHOUT GROSS ABNORMALITIES, AND THERE WAS PANNUS GROWTH ON THE SEWING CUFF. SPECIAL STAINS WERE NEGATIVE FOR ORGANISMS, AND NO ACUTE INFLAMMATION WAS PRESENT. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE CAUSE OF THE PANNUS FORMATION WAS DUE TO AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD AND THE ANALYSIS PERFORMED. THE CAUSE OF THE PANNUS FORMATION REMAINS UNKNOWN.
Description of Event or Problem · 1
A SJM MECHANICAL HEART VALVE WAS EXPLANTED DUE TO PANNUS FORMATION PREVENTING ADEQUATE VALVE OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715063 | SJM MECHANICAL HEART VALVE (UNKNOWN) | HEART-VALVE, MECHANICAL | LWQ | ST. JUDE MEDICAL PUERTO RICO, INC. (CS) | CVD0039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |